510(k) · Cleared
ClearedBeta-CrossLaps CalCheck 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Apr 4, 2017 as substantially equivalent to K162840 (Roche Diagnostics, 2017) after a 29-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Apr 4, 2017
- Review
- 29 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931172 (1993). 27 ancestors in all, the oldest K900779 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 5 generations between
- 3 generations backK102157 Elecsys Precicontrol MultimarkerRoche Diagnostics · 2010
- 2 generations backK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
- 1 generation backK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
- This deviceK170678 Beta-CrossLaps CalCheck 5Roche Diagnostics · 2017
Show all 9 generations
- Root · 9 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 8 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 7 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 6 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 5 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 4 generations backK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- 3 generations backK102157 Elecsys Precicontrol MultimarkerRoche Diagnostics · 2010
- 2 generations backK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
- 1 generation backK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
- This deviceK170678 Beta-CrossLaps CalCheck 5Roche Diagnostics · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −8 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −7 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −6 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −5 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −4 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| −3 | K102157 | Elecsys Precicontrol Multimarker | Roche Diagnostics | 2010 | — |
| −2 | K113546 | Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3… | Roche Diagnostics | 2012 | — |
| −1 | K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D… | Roche Diagnostics | 2017 | 2 |
| 0 (this device) | K170678 | Beta-CrossLaps CalCheck 5 | Roche Diagnostics | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Summary page 5…ssay analyzers. 3. TECHNOLOGICAL CHARACTERISTICS The following table compares the ß-CrossLaps CalCheck 5 with its predicate device, CalCheck Vitamin D Total II (k162840). Table 1: CalCheck Comparison Feature CalCheck Vitamin D Total II ß-CrossLaps CalCheck… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 27 ancestors have a recall of any class.
- 2 other devices also cite its predicate K162840.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This CalCheck set is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys ß-CrossLaps/serum reagent on the cobas e immunoassay analyzers,
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170678: Beta-CrossLaps CalCheck 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170678
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026